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Similarity in Pharmacokinetics of Oseltamivir and Oseltamivir Carboxylate in Japanese and Caucasian Subjects

From the University at Buffalo School of Pharmacy, Buffalo, New York (Dr Schentag); F. Hoffmann–La Roche, Inc, Palo Alto, California (Dr Hill, Dr Chu); and F. Hoffmann–La Roche Ltd, Basel, Switzerland (Dr Rayner).

The pharmacokinetics of oseltamivir and oseltamivir carboxylate in healthy Japanese (n = 14) and Caucasian (n = 14) males were compared. Subjects in each ethnic group were randomized to twice-daily oral oseltamivir 75 mg, 150 mg, or placebo for 13 doses. Oseltamivir was well tolerated across doses and ethnic groups. Oseltamivir was rapidly absorbed and hydrolyzed to oseltamivir carboxylate in all subjects. The mean plasma concentration–time profiles for oseltamivir and oseltamivir carboxylate were similar in Japanese and Caucasian subjects. At steady state, there was no evidence of any ethnic difference in the individual AUC_0–12 values for oseltamivir or oseltamivir carboxylate. Despite a significant difference in group mean body weight (approximately 20 kg) between the Japanese and Caucasian subjects, there was no evidence that dose-adjusted AUC_0–12 and C_max for oseltamivir carboxylate were affected by body weight or ethnicity. Day 7 trough concentrations (C_min) for oseltamivir carboxylate markedly exceeded the IC₅₀ (50% inhibitory concentration) against influenza A and B isolates. In conclusion, the results of this study support the use of the same dose regimens of oseltamivir in both Caucasian and Japanese subjects because of similarity in pharmacokinetics.

Key Words: Oseltamivir • oseltamivir carboxylate • pharmacokinetics • Japanese • Caucasian

Address for reprints: Jerome J. Schentag, PharmD, University at Buffalo School of Pharmacy, 517 Hochstetter Hall, Buffalo, NY 14260; e-mail: schentag{at}buffalo.edu.

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